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Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04770337
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
Neuroelectrics Corporation

Brief Summary:
This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.

Condition or disease Intervention/treatment Phase
Refractory Epilepsy Device: STARSTIM device Device: Sham Device Not Applicable

Detailed Description:
Study design is an evaluation of the STARSTIM device (tDCS) in subjects over 9 years of age, diagnosed with epilepsy with focal seizures with or without focal to bilateral tonic clonic seizures. Seizure diaries will be collected for 12 weeks to establish a rate of seizure for each subject prior to treatment. Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment. Neither the study investigator nor subject shall be notified of the treatment assignment. Treatment will be done daily at the investigator's site for 10 days. A Seizure Diary will be maintained through the course of the treatment and the follow up period. Subjects will have 3 follow up visits to evaluate their seizure rate, adverse events, medications and quality of life. A Data Safety Monitoring Board will be utilized to evaluate safety events through study milestones. Seizure frequency rates pre, during and post treatment will be evaluated for both the active and sham treatment arms.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multiple site, randomized, double blinded parallel-group controlled study
Masking: Double (Participant, Investigator)
Masking Description: Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment. Neither the study investigator nor subject shall be notified of the treatment assignment.
Primary Purpose: Treatment
Official Title: STARSTIM: SAFETY AND THERAPEUTIC MEASURES OF TRANSCRANIAL CATHODAL DIRECT CURRENT STIMULATION (TDCS) IN PATIENTS WITH REFRACTORY FOCAL EPILEPSY
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : July 31, 2023


Arm Intervention/treatment
Sham Comparator: Sham treatment
Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.
Device: Sham Device
Intervention which uses enough currents to generate a sensory feedback similar to that of active stimulation via electrodes on the scalp

Experimental: STARSTIM device treatment
Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.
Device: STARSTIM device
Cathodal Transcranial Direct Current Stimulation (tDCS). Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered to the brain area of interest via electrodes on the scalp.




Primary Outcome Measures :
  1. Percent change in seizure frequency from 12-week baseline to the 12 weeks post-randomization, which includes the two-week active intervention [ Time Frame: From 12-week baseline to the 12 weeks post-randomization ]

Secondary Outcome Measures :
  1. Presence or absence of treatment 'response' within the six weeks following initiative of intervention (i.e. between baseline and visit 12), where responders are those subjects with at least 50% reduction in seizure rate [ Time Frame: Within the six weeks following initiative of intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 9 years old or older
  2. Diagnosis of epilepsy with focal seizures with or without focal to bilateral tonic clonic seizures (International League Against Epilepsy classification). Diagnosis established by both clinical history and an EEG consistent with focal seizures.
  3. Epilepsy is refractory to treatment, defined as: failure to achieve adequate seizure control despite demonstrated compliance, according to medical records, on at least two (2) FDA-approved ASDs at a daily dose considered therapeutic for the patient's demographic according to package labeling, within approximately the last 3 years.
  4. Seizure frequency >= 3 and <= 20 per month, over the past year.
  5. Currently on 1-4 ASDs with no changes in antiepileptic drug doses in the 3 weeks prior to enrollment in the study and no planned dose changes during the trial. Changes after enrollment are permitted only if clinically necessary.
  6. An MRI scan of the brain using 1.5 Tesla magnet, or greater, with T1, T2, and FLAIR sequences, performed within past 3 years and more recently than any craniotomy or skull burr hole procedure.
  7. Seizure focus that allows design of an appropriate stimulation montage
  8. Available seizure history and supporting data
  9. All female study subjects of child-bearing age are required to have a pregnancy test.

    Additionally, all females of childbearing potential will be required to use an effective method of birth control (defined as having a documented failure rate of <=1%; for women using enzyme-inducing ASDs hormonal contraceptives will not be considered as effective).

  10. Written informed consent obtained from study subject or subject's legal representative and ability for study subject to comply with the requirements of the study.
  11. Assent from pediatric subjects when appropriate.

Exclusion Criteria:

  1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the integrity of the data.
  2. Evidence for more than one seizure focus. (NOTE: For this study, a seizure focus is defined as a cortical region confined to one hemisphere and either one lobe or on a junction of two adjacent lobes from which seizures arise, as documented by scalp or intracranial EEG, that is either supported or not refuted by MRI, and either supported or not refuted by clinical semiology).
  3. Seizure focus is one of: interhemispheric, cingulate, or orbitofrontal
  4. Seizure focus is hemispheric or poorly defined
  5. History of psychogenic nonepileptic seizures, or physiologic nonepileptic seizures and Non-epileptogenic events, including suspicion for or a significant history of syncope
  6. Seizures of generalized onset
  7. Status epilepticus in the last 12 months
  8. Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may compromise interfere, limit, effect or reduce the subject's ability to complete a study of 24 weeks duration
  9. Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may adversely impact the safety of the subject or the integrity of the data.
  10. Damaged skin on scalp that may interfere with tDCS stimulation.
  11. Pregnant or unwilling to practice birth control during participation in the study.
  12. Nursing mothers.
  13. Any cranial metal implants (excluding ≦1 mm thick epicranial titanium skull plates and dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagus nerve stimulator).
  14. Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.
  15. A history of addiction to, dependence on, abuse of, misuse of, distribution of, or use of any illicit substance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770337


Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Abou-Khalil Bassel    615-875-2532    bassel.abou-khalil@vumc.org   
Contact: Melissa Osborn       melissa.osborn@vumc.org   
Sponsors and Collaborators
Neuroelectrics Corporation
Investigators
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Principal Investigator: Abou-Khalil Bassel Vanderbilt University Medical Center
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Responsible Party: Neuroelectrics Corporation
ClinicalTrials.gov Identifier: NCT04770337    
Other Study ID Numbers: NE001
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases